Clinical trial • Phase III • Neurology

CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Chronic migraine

Phase III trial of CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Chronic migraine.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Chronic migraine
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme|Other

Key dates

Initial CTIS Submission Date
15-05-2025
First CTIS Authorization Date
01-09-2025

Trial design

Randomised, placebo injections at pericranial and cervical points (placebo to clostridium botulinum neurotoxin type a (150 kd) described as comparator arm).-controlled Phase III trial in Germany, Austria, Italy and others.

Randomised
Yes
Comparator
Placebo injections at pericranial and cervical points (Placebo to Clostridium Botulinum neurotoxin type A (150 kD) described as comparator arm).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
269
Trial Duration For Participant
196

Eligibility

Recruits 269 adults.

Inclusion criteria

  • {"criterion_text":"- At least 18 years of age, at the time of signing the informed consent;\n- Participant has a diagnosis of CM with or without aura according to the International Classification of Headache Disorders Edition 3 criteria for ≥ 12 months and is able to distinguish migraine headaches from all other types of headaches;\n- Participant age < 50 years at the time of migraine onset;\n- Participant meeting the following headache and migraine day criteria in each of the 3 months prior to screening: history of ≥ 15 headache days per month and history of ≥ 8 migraine days per month; and\n- During the last 28 days of the screening period, participant experiencing: ≥ 15 headache days and ≥ 8 migraine days that qualify as such per the headache diary."}

Exclusion criteria

  • {"criterion_text":"- Diagnosis of other primary headache types, except tension-type headache, which is permitted;\n- Diagnosis of aura without headache, migraine with brainstem aura, hemicrania continua, hypnic headache, hemiplegic migraine, retinal migraine, persistent aura without infarction, migraine aura-triggered seizure, or previous migrainous infarction;\n- Diagnosis of secondary headache types, except medication overuse headache, which is permitted;\n- Currently taking > 1 prescribed drug for the preventive treatment of migraine;\n- Discontinuation of anti-calcitonin gene-related peptide (CGRP) / anti-CGRP receptor monoclonal antibody treatment less than 5 months prior to screening."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) – Dose A.","definition_or_measurement_approach":"Change from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection); baseline defined as 28 days prior to baseline visit."}

Secondary endpoints

  • {"endpoint_text":"- Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) – Dose B.","definition_or_measurement_approach":"Change from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection)."}
  • {"endpoint_text":"- Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) – Dose A.","definition_or_measurement_approach":"Change from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection)."}
  • {"endpoint_text":"- Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) – Dose B.","definition_or_measurement_approach":"Change from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection)."}
  • {"endpoint_text":"- Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) – Dose A.","definition_or_measurement_approach":"Change from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection)."}
  • {"endpoint_text":"- Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) – Dose B.","definition_or_measurement_approach":"Change from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection)."}
  • {"endpoint_text":"- Change in frequency of migraine days from baseline (baseline monthly migraine days divided by 2) to two-week end-of-cycle periods (weeks 11 and 12 of Cycle 1 to 4).","definition_or_measurement_approach":"Frequency change measured from baseline (baseline monthly migraine days/2) to consecutive two-week end-of-cycle periods (weeks 11 and 12 of Cycles 1–4)."}
  • {"endpoint_text":"- Percentage of participants who reported at least a 50% reduction in mean monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection).","definition_or_measurement_approach":"Responder rate: proportion of participants with ≥50% reduction in mean monthly migraine days from baseline to Month 6 (weeks 21–24 after first injection)."}
  • {"endpoint_text":"- Incidence of treatment‑emergent adverse events (TEAEs) related to treatment as assessed by the investigator in the placebo-controlled period (PCP).","definition_or_measurement_approach":"Incidence of TEAEs assessed by investigators during the placebo-controlled period."}

Recruitment

Registry Or Advocacy Recruitment
True - Site-and-Patient-Advocacy-Contact-List-for-ICF_AT_Public document present (specific registry/advocacy organisation names not listed in available JSON).
Planned Sample Size
269
Recruitment Window Months
32
Consent Approach
Informed consent is obtained from the participant (study includes adults ≥18 years). Country/language-specific subject information and informed consent forms are provided (documents in German, Italian, Spanish, Polish, Danish, Slovak, French, Czech and others are present in the document list). Separate pregnancy/newborn ICF addenda are available in several countries. Specific assent procedures are not described in the available data.

Methods

  • Doctor-to-patient letters (country-specific documents present: e.g. IT, FR, DNK) — clinical-site mediated letters from investigators to patients.
  • GP letters (document: K2_M602011084_GP_Letter_IT_ITA_Public) — outreach to general practitioners (Italy).
  • Patient letters/posters/flipcharts/brochures (multiple country-specific documents available) — printed recruitment materials for use at sites and public areas (documents present for DE/AT/IT/ES/PL/DNK/SK/CZ/FR).
  • Site-to-patient/site-patient letters and brochures (country-specific) — materials distributed by participating sites to potential participants.
  • Recruitment brochures and posters tailored per country (documents labelled e.g. Recruitment-Brochure, Poster, Flipchart).

Geography

Total Number Of Sites
60
Total Number Of Participants
506

Germany

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
03-09-2025
Processing Time Days
27
Number Of Sites
6
Number Of Participants
46

Sites

Site Name
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie
Principal Investigator Name
Hartmut Göbel
Principal Investigator Email
hg@schmerzklinik.de
Contact Person Name
Hartmut Göbel
Contact Person Email
hg@schmerzklinik.de
Site Name
Vitos Orthopaedische Klinik Kassel gGmbH
Principal Investigator Name
Miriam Butz
Principal Investigator Email
miriam.butz@vitos-okk.de
Contact Person Name
Miriam Butz
Contact Person Email
miriam.butz@vitos-okk.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Neurologie
Principal Investigator Name
Bianca Raffaelli
Principal Investigator Email
kopfschmerz@charite.de
Contact Person Name
Bianca Raffaelli
Contact Person Email
kopfschmerz@charite.de
Site Name
Studienzentrum Nord-West
Principal Investigator Name
Joachim Springub
Principal Investigator Email
joachim.springub@ewetel.net
Contact Person Name
Joachim Springub
Contact Person Email
joachim.springub@ewetel.net
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik und Poliklinik für Neorologie
Principal Investigator Name
Robert Fleischmann
Principal Investigator Email
robert.fleischmann@med.uni-greifswald.de
Contact Person Name
Robert Fleischmann
Site Name
Kopfschmerzzentrum Frankfurt
Principal Investigator Name
Charly Gaul
Principal Investigator Email
c.gaul@kopfschmerz-frankfurt.de
Contact Person Name
Charly Gaul

Austria

Earliest CTIS Part Ii Submission Date
18-07-2025
Latest Decision Or Authorization Date
05-09-2025
Processing Time Days
49
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Department Name
Neurologie
Principal Investigator Name
Sonja-Maria Tesar
Principal Investigator Email
Sonja-Maria.Tesar@kabeg.at
Contact Person Name
Sonja-Maria Tesar
Contact Person Email
Sonja-Maria.Tesar@kabeg.at
Site Name
Medizinische Universitaet Innsbruck
Department Name
Univ.-Klinik für Neurologie
Principal Investigator Name
Gregor Brössner
Principal Investigator Email
Gregor.broessner@i-med.ac.at
Contact Person Name
Gregor Brössner
Contact Person Email
Gregor.broessner@i-med.ac.at

Italy

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
01-09-2025
Processing Time Days
67
Number Of Sites
5
Number Of Participants
34

Sites

Site Name
Irccs San Raffaele Roma S.r.l.
Department Name
Unità per la cura e la ricerca su cefalee e dolore
Principal Investigator Name
Piero Barbanti
Principal Investigator Email
piero.barbanti@sanraffaele.it
Contact Person Name
Piero Barbanti
Contact Person Email
piero.barbanti@sanraffaele.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Centro Cefalee e Farmacologia Clinica
Principal Investigator Name
Alberto Chiarugi
Principal Investigator Email
alberto.chiarugi@unifi.it
Contact Person Name
Alberto Chiarugi
Contact Person Email
alberto.chiarugi@unifi.it
Site Name
Istituto Auxologico Italiano
Department Name
UO Neurologia – Clinical Trial Center
Principal Investigator Name
Alberto Doretti
Principal Investigator Email
a.doretti@auxologico.it
Contact Person Name
Alberto Doretti
Contact Person Email
a.doretti@auxologico.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
UOC Neurologia
Principal Investigator Name
Massimo Filippi
Principal Investigator Email
filippi.massimo@hsr.it
Contact Person Name
Massimo Filippi
Contact Person Email
filippi.massimo@hsr.it
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
Brain and Behavioral Sciences
Principal Investigator Name
Cristina Tassorelli
Principal Investigator Email
cristina.tassorelli@mondino.it
Contact Person Name
Cristina Tassorelli
Contact Person Email
cristina.tassorelli@mondino.it

Denmark

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
118
Number Of Sites
2
Number Of Participants
27

Sites

Site Name
Odense University Hospital
Department Name
Department of Neurology
Principal Investigator Name
Dagmar Beier
Principal Investigator Email
dagmar.beier@rsyd.dk
Contact Person Name
Dagmar Beier
Contact Person Email
dagmar.beier@rsyd.dk
Site Name
Rigshospitalet
Department Name
Danish Headache Center, Department of Neurology
Principal Investigator Name
Henrik Schytz
Principal Investigator Email
hovedpine@regionh.dk
Contact Person Name
Henrik Schytz
Contact Person Email
hovedpine@regionh.dk

Slovakia

Earliest CTIS Part Ii Submission Date
07-07-2025
Latest Decision Or Authorization Date
01-09-2025
Processing Time Days
56
Number Of Sites
4
Number Of Participants
69

Sites

Site Name
Konzilium s.r.o.
Principal Investigator Name
Magdaléna Perichtová
Principal Investigator Email
erichtova.md@gmail.com
Contact Person Name
Magdaléna Perichtová
Contact Person Email
erichtova.md@gmail.com
Site Name
MUDr. Beata Dupejova neurologicka ambulacia s.r.o.
Principal Investigator Name
Beáta Dupejová
Principal Investigator Email
dupejova@gmail.com
Contact Person Name
Beáta Dupejová
Contact Person Email
dupejova@gmail.com
Site Name
Neures s.r.o.
Department Name
Neurologická ambulancia
Principal Investigator Name
Renáta Smiková
Principal Investigator Email
renata.smikova@gmail.com
Contact Person Name
Renáta Smiková
Contact Person Email
renata.smikova@gmail.com
Site Name
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas
Department Name
Neurologické oddelenie
Principal Investigator Name
Michal Kováčik
Principal Investigator Email
kovacik@nsplm.sk
Contact Person Name
Michal Kováčik
Contact Person Email
kovacik@nsplm.sk

Poland

Earliest CTIS Part Ii Submission Date
04-08-2025
Latest Decision Or Authorization Date
20-11-2025
Processing Time Days
109
Number Of Sites
19
Number Of Participants
183

Sites

Site Name
Neurocor Banaszkiewicz Tomaszewski Lekarze sp.p.
Principal Investigator Name
Krzysztof Banaszkiewicz
Principal Investigator Email
krzysztof@banaszkiewicz.ne
Contact Person Name
Krzysztof Banaszkiewicz
Contact Person Email
krzysztof@banaszkiewicz.ne
Site Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Principal Investigator Name
Magdalena Boczarska-Jedynak
Principal Investigator Email
m.boczarska@instytutboczarska.pl
Contact Person Name
Magdalena Boczarska-Jedynak
Site Name
Silmedic Sp. z o.o.
Principal Investigator Name
Ilona Pałka-Kisielowska
Principal Investigator Email
ikisielowska@silmedic.p
Contact Person Name
Ilona Pałka-Kisielowska
Contact Person Email
ikisielowska@silmedic.p
Site Name
Jan Banach Research Spot
Principal Investigator Name
Lucyna Horodecka-Wardęga
Principal Investigator Email
lhwardega@specjalistycznegabinety.pl
Contact Person Name
Lucyna Horodecka-Wardęga
Site Name
Futuremeds Sp. z o.o. (Ul. Legnicka 16)
Principal Investigator Name
Aleksandra Herrera-Sokołowska
Principal Investigator Email
aleksandra.herrera@futuremeds.com
Contact Person Name
Aleksandra Herrera-Sokołowska
Site Name
ETG Lublin Sp. z o.o. (Ul. Wladyslawa Kunickiego 26a)
Principal Investigator Name
Dominika Tomaka
Principal Investigator Email
d.tomaka@etg-network.com
Contact Person Name
Dominika Tomaka
Contact Person Email
d.tomaka@etg-network.com
Site Name
Athleticomed Sp. z o.o.
Principal Investigator Name
Magdalena Nowaczewska
Principal Investigator Email
m.nowaczewska@athleticomed.pl
Contact Person Name
Magdalena Nowaczewska
Contact Person Email
m.nowaczewska@athleticomed.pl
Site Name
Krakowska Akademia Neurologii Sp. z o.o.
Principal Investigator Name
Monika Rudzińska-Bar
Principal Investigator Email
mrudzinska-bar@uafm.edu.pl
Contact Person Name
Monika Rudzińska-Bar
Contact Person Email
mrudzinska-bar@uafm.edu.pl
Site Name
MIGRE Polskie Centrum Leczenia Migreny ANNA GRYGLAS-DWORAK
Principal Investigator Name
Anna Gryglas-Dworak
Principal Investigator Email
anna.gryglas@gmail.com
Contact Person Name
Anna Gryglas-Dworak
Contact Person Email
anna.gryglas@gmail.com
Site Name
Indywidualna Praktyka Lekarska Dr. hab. med. Anna Szczepańska-Szerej
Principal Investigator Name
Anna Szczepańska-Szerej
Principal Investigator Email
aszerej@poczta.onet.pl
Contact Person Name
Anna Szczepańska-Szerej
Contact Person Email
aszerej@poczta.onet.pl
Site Name
Centrum Medyczne Neuromed Sp. z o.o.
Principal Investigator Name
Paweł Lisewski
Principal Investigator Email
lisewski.p@gmail.com
Contact Person Name
Paweł Lisewski
Contact Person Email
lisewski.p@gmail.com
Site Name
Etg Neuroscience Sp. z o.o.
Principal Investigator Name
Aleksandra Karbowniczek
Principal Investigator Email
a.karbowniczek@neuroscience.com.pl
Contact Person Name
Aleksandra Karbowniczek
Site Name
Clinirem Sp. z o.o.
Principal Investigator Name
Urszula Chyrchel-Paszkiewicz
Principal Investigator Email
pgluchyrchel@gmail.com
Contact Person Name
Urszula Chyrchel-Paszkiewicz
Contact Person Email
pgluchyrchel@gmail.com
Site Name
Solumed Sp. z o.o. sp.k.
Principal Investigator Name
Olgierd Stefański
Principal Investigator Email
olgierd_stefanski@interia.pl
Contact Person Name
Olgierd Stefański
Contact Person Email
olgierd_stefanski@interia.pl
Site Name
Futuremeds Sp. z o.o. (Ul. Mikolaja Kopernika 32)
Principal Investigator Name
Karolina Porębska
Principal Investigator Email
karolina.porebska@futuremeds.com
Contact Person Name
Karolina Porębska
Site Name
Pratia S.A. (Ul. Pana Tadeusza 2)
Principal Investigator Name
Katarzyna Kasprzyk
Principal Investigator Email
kkasprzyk-galon@pratia.pl
Contact Person Name
Katarzyna Kasprzyk
Contact Person Email
kkasprzyk-galon@pratia.pl
Site Name
ETG Lublin Sp. z o.o. (Ul. Czarnieckiego 5)
Principal Investigator Name
Barbara Pietruszewska
Principal Investigator Email
b.pietruszewska@etg-network.com
Contact Person Name
Barbara Pietruszewska
Site Name
Pratia S.A. (Ul. Chrzanowskiego 3 Lok 5)
Principal Investigator Name
Iwo Sługocki
Principal Investigator Email
islugocki@pratia.pl
Contact Person Name
Iwo Sługocki
Contact Person Email
islugocki@pratia.pl
Site Name
Etg Zamosc Sp. z o.o.
Principal Investigator Name
Kajetan Mazurek
Principal Investigator Email
kajetan.mazurek@gmail.com
Contact Person Name
Kajetan Mazurek
Contact Person Email
kajetan.mazurek@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
04-07-2025
Latest Decision Or Authorization Date
05-09-2025
Processing Time Days
63
Number Of Sites
13
Number Of Participants
83

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology Department
Principal Investigator Name
Patricia Pozo Rosich
Principal Investigator Email
patricia.pozo@vhir.org
Contact Person Name
Patricia Pozo Rosich
Contact Person Email
patricia.pozo@vhir.org
Site Name
Hospital Universitario 12 De Octubre
Department Name
Neurology Department
Principal Investigator Name
Alejandro Herrero San Martín
Principal Investigator Email
alexportalrubio@hotmail.com
Contact Person Name
Alejandro Herrero San Martín
Contact Person Email
alexportalrubio@hotmail.com
Site Name
Fundación Neuropolis
Department Name
Neurology Department
Principal Investigator Name
Antonio Oliveros-Cid
Principal Investigator Email
aoliverosc.neuropolis@gmail.com
Contact Person Name
Antonio Oliveros-Cid
Site Name
Hospital Universitario La Paz
Department Name
Neurology Department
Principal Investigator Name
Javier Diaz de Terán Velasco
Principal Investigator Email
javierddt@gmail.com
Contact Person Name
Javier Diaz de Terán Velasco
Contact Person Email
javierddt@gmail.com
Site Name
Consorci Sanitari De Terrassa
Department Name
Neurology department
Principal Investigator Name
Gabriel Salazar Tortolero
Principal Investigator Email
GSalazar@CST.CAT
Contact Person Name
Gabriel Salazar Tortolero
Contact Person Email
GSalazar@CST.CAT
Site Name
Hospital Alvaro Cunqueiro
Department Name
Neurology Department
Principal Investigator Name
Maria Dolores García Bargo
Principal Investigator Email
Maria.Dolores.Garcia.Bargo@sergas.es
Contact Person Name
Maria Dolores García Bargo
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology Department
Principal Investigator Name
Samuel Diaz Insa
Principal Investigator Email
sdiazinsa@yahoo.es
Contact Person Name
Samuel Diaz Insa
Contact Person Email
sdiazinsa@yahoo.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurology Department
Principal Investigator Name
Lucia de Flores Garcia Trujillo
Principal Investigator Email
floreslucia78@hotmail.com
Contact Person Name
Lucia de Flores Garcia Trujillo
Contact Person Email
floreslucia78@hotmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Neurology Department
Principal Investigator Name
Omar Hamad Cueto
Principal Investigator Email
ohacu@gmail.com
Contact Person Name
Omar Hamad Cueto
Contact Person Email
ohacu@gmail.com
Site Name
Hospital Vithas Parque San Antonio
Department Name
Neurology Department
Principal Investigator Name
Maria Victoria Castro
Principal Investigator Email
v.castro.eecc@gmail.com
Contact Person Name
Maria Victoria Castro
Contact Person Email
v.castro.eecc@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Neurology Departmen
Principal Investigator Name
Victor Obach
Principal Investigator Email
vobach@clinic.ca
Contact Person Name
Victor Obach
Contact Person Email
vobach@clinic.ca
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Neurology Department
Principal Investigator Name
Carmen Gonzalez Oria
Principal Investigator Email
carmengoria@hotmail.com
Contact Person Name
Carmen Gonzalez Oria
Contact Person Email
carmengoria@hotmail.com
Site Name
Hospital Blua Sanitas Valdebebas
Department Name
Neurology
Principal Investigator Name
Angel Aledo Serrano
Principal Investigator Email
as.aledo@gmail.com
Contact Person Name
Angel Aledo Serrano
Contact Person Email
as.aledo@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
67
Number Of Sites
6
Number Of Participants
39

Sites

Site Name
Neuropsychiatrie s.r.o.
Principal Investigator Name
Jakub Hort
Principal Investigator Email
neuropsychiatrie@gmail.com
Contact Person Name
Jakub Hort
Contact Person Email
neuropsychiatrie@gmail.com
Site Name
CLINTRIAL s.r.o.
Principal Investigator Name
Miroslava Chýlova
Principal Investigator Email
m.chylova@clintrial.cz
Contact Person Name
Miroslava Chýlova
Contact Person Email
m.chylova@clintrial.cz
Site Name
Pratia Brno s.r.o.
Principal Investigator Name
Jitka Grohová
Principal Investigator Email
grohova@tiscali.cz
Contact Person Name
Jitka Grohová
Contact Person Email
grohova@tiscali.cz
Site Name
NeuroMed Zlín s.r.o.
Department Name
Neurologická ambulance
Principal Investigator Name
Monika Záhumenská
Principal Investigator Email
zahumenska@seznam.cz
Contact Person Name
Monika Záhumenská
Contact Person Email
zahumenska@seznam.cz
Site Name
Fakultní nemocnice Hradec Králové
Department Name
Neurologická klinika
Principal Investigator Name
Zbyšek Pavelek
Principal Investigator Email
zbysek.pavelek@fnhk.cz
Contact Person Name
Zbyšek Pavelek
Contact Person Email
zbysek.pavelek@fnhk.cz
Site Name
Axon Clinical s.r.o.
Principal Investigator Name
Zuzana Matoušová
Principal Investigator Email
zuzmat62@gmail.com
Contact Person Name
Zuzana Matoušová
Contact Person Email
zuzmat62@gmail.com

France

Earliest CTIS Part Ii Submission Date
02-06-2025
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
122
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Centre Hospitalier Universitaire de Grenoble, Alpes, Neurology, CS 10 217, Pavillon de Neurologie
Principal Investigator Name
Mathieu VAILLANT
Principal Investigator Email
MVaillant@chu-grenoble.fr
Contact Person Name
Mathieu VAILLANT
Contact Person Email
MVaillant@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
CHU Nantes, Hopital Guillaume & René Laennec
Principal Investigator Name
Emmanuelle BOUGOUIN-KUHN
Principal Investigator Email
emmanuelle.bougouin@chu-nantes.fr
Contact Person Name
Emmanuelle BOUGOUIN-KUHN
Site Name
University Hospital Of Clermont-Ferrand
Department Name
CHU Clermont-Ferrand, CHU Gabriel Montpied
Principal Investigator Name
Xavier MOISSET
Principal Investigator Email
xmoisset@chu-clermontferrand.fr
Contact Person Name
Xavier MOISSET

Sponsor

Primary sponsor

Full Name
Merz Therapeutics GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
PPD Global Limited
Responsibilities
[{"code":"1"},{"code":"12"},{"code":"2"},{"code":"5"},{"code":"6"},{"code":"8"}]
Name
PPD Global Central Labs
Responsibilities
[{"code":"4"}]
Name
Pharmaceutical Product Development LLC
Responsibilities
[{"code":"4"}]
Name
Almac Clinical Services Limited
Responsibilities
[{"code":"14"}]
Name
Almac Clinical Technologies LLC
Responsibilities
[{"code":"3"}]
Name
Almac Clinical Services (Ireland) Limited
Responsibilities
[{"code":"14"}]

Third parties

  • {"country":"Germany","full_name":"Toxologics GmbH","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"[{\"code\":\"1\"},{\"code\":\"12\"},{\"code\":\"2\"},{\"code\":\"5\"},{\"code\":\"6\"},{\"code\":\"8\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Infraserv GmbH & Co. Hoechst KG","duties_or_roles":"[{\"code\":\"15\",\"value\":\"24 hours emergency unblinding service and hotline\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"[{\"code\":\"7\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Eurofins BioPharma Product Testing Munich GmbH","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"[{\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"[{\"code\":\"3\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"[{\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS
Active Substance
CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAMUSCULAR INJECTION
Route
INTRAMUSCULAR INJECTION
Maximum Dose
780 U unit(s)
Investigational Product Name
Placebo to Clostridium Botulinum neurotoxin type A (150 kD)
Modality
Other

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